For Immediate Release
William J. Wechter
Chairman and CSO
Tel: (909) 559-4903
FAX: (909) 796-0290
Encore Pharmaceuticals Begins Phase IIa Clinical Trial In Prostate Cancer Patients
Encore Pharmaceuticals, Inc., Loma Linda, California; April 15, 1999
Encore Pharmaceuticals, Inc. announced today that it had dosed the first patients in a Phase IIa trial of its lead compound E-7869 in advanced or hormone refractory prostate cancer patients. The trial, involving 36 subjects, is anticipated to be completed within 12 months. It will assess multiple dosage levels of the drug for safety, tolerance, pharmacokinetics and effects on disease progression in prostate cancer patients. The Company also has underway a Phase I dose escalation study of E-7869 in healthy volunteers directed at separately assessing the drug's safety and pharmacokinetics.
E-7869 is a proprietary component of the marketed non-steriodal anti-inflammatory drug (NSAID) flurbiprofen. In animal models of cancer, E-7869, which lacks the gastrointestinal side effects of the NSAID class of drugs, has demonstrated marked anti-tumor and anti-metastatic activity. E-7869 does not inhibit COX-1 or 2 enzymes, but appears to modulate expression of COX-2, thus distinguishing it from the selective COX-2 enzyme inhibitors (Celebrex® and Vioxx®) or the NSAIDs. Dr. William Wechter and his colleagues discovered this anti-cancer activity through research conducted in the Laboratory of Chemical Endocrinology at the Loma Linda University Medical Center (LLUMC) in Loma Linda, California. LLUMC has licensed E-7869 on an exclusive basis to Encore Pharmaceuticals.
Regarding the clinical trials with E-7869, Dr. Wechter, Chairman and Chief Executive Officer of Encore Pharmaceuticals commented "We are pleased to have these important studies underway. We hope to demonstrate the safety of E-7869 and determine the appropriate dose of the drug in prostate cancer patients." He concluded, "If E-7869 holds up in these ongoing trials, we are ready to initiate pivotal Phase II/III studies in prostate cancer patients by the middle of next year." Other Phase II studies are planned in colon, breast and lung cancer.
Encore Pharmaceuticals is currently in active discussions with multi-national pharmaceutical companies to partner the development and commercialization of E-7869.
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